The term insomnia is derived from the Latin words in, meaning "not", and somus, meaning "sleep". Thus insomnia means "the inability to sleep" (Thorpy and Yager, 2001). Patients perceive that their sleep is inadequate or abnormal. The symptoms include: difficulty initiating sleep, frequent awakenings from sleep, a short sleep time and non restorative sleep (Kryger et al, 1989). Passiflora incarnata 0 is a remedy that is indicated in the Homoeopathic Materia Medica for treating insomnia, when the type of sleeplessness which occurs is an inability to fall asleep due to mental anxiety, stress, or from nervous excitement. This study aimed to ascertain the efficacy of the homoeopathic remedy, Passiflora incarnata 0, on difficulty in falling asleep. The quality of sleep was assessed in terms of duration of sleep, degree of feeling refreshed upon waking, and satisfaction with sleep. This study was a double blind placebo controlled study with a sample of thirty participants, males and females between the ages of 19 and 49. Participants were recruited by means of advertisements in local newspapers, emails and pamphlets that were distributed in and around the University of Johannesburg, the health clinic, health shops, shopping malls, residential areas and at the Sleep Unit at the University of Witwatersrand. Participants, who met the inclusion criteria and completed the initial questionnaire (Appendix B), were required to sign the consent form (Appendix A). Participants were randomly divided into two groups of fifteen; one group received Passiflora incarnata 0, and the other group received the placebo. The groups were instructed to dilute fifty drops of the medication in 20m1 (4 tsp) of water. The medication was to be taken orally twenty minutes before going to bed, for a period of four weeks. Neither the participant nor the researcher was aware of what they had received. Furthermore participants were given a sleep diary (Appendix C) at the initial consultation which they were required to complete every morning. An appointment was made with the participant for a follow up visit on weeks two and four. At each follow up visit the sleep diary (Appendix C) was checked to encourage compliance and a case history (Appendix D) was taken. The participants' blood pressure, pulse rate, respiratory rate and temperature were taken to monitor their wellbeing. The data obtained from the initial questionnaire and the sleep diary was statistically analysed using the General Linear Model: Repeated Measures, Mann- Whitney test (nonparametric test), Cross Tabulation, Fisher's exact test and Regression analysis. Statistical analysis showed no significant differences in the P- values between the Passiflora and placebo groups. Therefore the null hypothesis was accepted. However, within the Passiflora group, the males did have a consistently higher average in the number of hours slept over the 4 week period and they also noticed more of an improvement in their sleeping pattern compared to the females taking the medication. With regards to the satisfaction of sleep over the 4 weeks, the males, taking Passiflora incarnata 0 had more satisfaction with their sleep. The overall P- value was P= 0,046. This was statistically significant. Preliminary findings suggest that the homoeopathic complex Passiflora incarnata 0 may be more effective for insomnia in males than in females.